Ethical considerations for using alternative methods of consent in neonatal clinical trials: recommendations from a...

Area of Science:

• Neonatal research ethics
• Clinical trial methodology

Background:

• Neonatal clinical trials face challenges with low enrollment, consent acquisition, and biased populations.
• Alternative consent methods are proposed but involve ethical complexities.

Purpose of the Study:

• To develop recommendations for using alternative consent methods in neonatal clinical trials.
• To address ethical trade-offs associated with alternative consent approaches.

Main Methods:

• A modified Delphi approach was employed with diverse stakeholders.
• The process aimed to achieve consensus on recommendations for alternative consent in neonatal research.

Main Results:

• Twenty-one recommendations were generated across three categories: appropriateness of alternative consent, pre-allocation information and opt-out, and post-allocation information.
• Specific guidance was provided for deciding on alternative consent, sharing information with families, and communication post-allocation.

Conclusions:

• The recommendations can guide researchers, clinicians, regulators, and funders on using alternative consent methods in neonatal trials.
• Further evaluation of these recommendations in practice and addressing areas of non-consensus is warranted.